• 의료법학
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• 제24권3호
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• pp.3-26
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• 2023

의료인이 환자에게 직접 조제한다는 이유로 의약품공급자로부터 의약품을 취득하여 보관하고 있다가 스스로에게 투약한 경우의 약사법상 쟁점을 검토하였다. 의료인이 자가 투약 행위를 한 경우 의약품공급자나 의료인이 약사법에 따라 형사처벌될 수 있다. 그 가벌성은 약사법에서 규정한 의약품 유통 질서 훼손에 있다. 첫째, 의약품공급자가 의료인에게 의약품을 판매하는 것은 약사법 제47조 제1항 제1호 나목 위반죄의 구성요건에 해당한다. 다만, 약사법상 허용되는 직접 조제를 위해 판매한 경우 형법상 정당행위에 해당하여 위법성이 조각된다. 그러나 의약품공급자가 의료인의 자가 투약 목적을 알면서도 의약품을 판매한다면 위법성이 조각되지 않아서 형사처벌될 수 있다. 둘째, 의료인이 약사법상 직접 조제를 위하여 의약품을 취득한다고 명시적, 묵시적으로 의약품공급자를 기망하고 의약품을 취득하여 자가 투약한 경우, 기망에 의한 의약품 교부로 의료인에게 형법상 사기죄가 성립할 수 있다. 셋째, 의료인의 자가 투약 시 약사법상 조제 행위가 수반되므로 약사법 제23조 제1항 위반죄의 구성요건에 해당한다. 이때 위법성이 조각되지 않는다. 왜냐하면 의료인의 자가 투약 행위는 약사법에서 의료인에게 부여한 특별한 지위를 남용한 것으로 의약품 유통 질서를 해치고 의약분업의 취지를 훼손하는 것이어서 형법상 정당행위로 볼 수 없기 때문이다.

• 대한한의학회지
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• 제35권3호
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• 한국의사학회지
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• 제26권2호
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• pp.175-185
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• 2013

Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.

• 대한한의학방제학회지
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• 제23권1호
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• pp.1-14
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• 2015

Objectives : In Pharmaceutical Affairs Act, herbal medicinal preparations are defined as medicines made by Korean medicine principles. But in Act, Korean medicine principles are vague. Thus, there is a request to explain what the Korean medicine principles are. The aim of this study is to suggest implications of Korean medicine principles in definition of herbal medicinal preparations. Methods : With regard for definition of Korean medicine principles, we referred to the domestic and foreign regulations and literature about the history of herbal medicinal preparations. As a result, the meaning of Korean medicine principles was historically examined from various angles. Results : Through this study, we studied the Korean medicine principles from the past medical history. Due to the broad definition of Korean medicinal principles, we tried to extract general ideas of medicine principles first. We also found that we had scientific formulations based on korean medicine principles which could be used in modern society. In the end, we found that numerous medicine principles which include ‘Four qi and five flavors theory’, ‘Processing of medicinals’, ‘Yin and yang theory’, ‘Five phases theory’, ‘Meridian entry of viscera and bowels theory’, ‘Herb Couplet Interaction theory’, ‘Sovereign, minister, assistant and courier theory’, etc. Conclusions : Innumerable principles used from the past existed. These principles were broad and could be used as modern scientific principles. Based on these facts, we illustrated details of Korean medicine principles, hope this principles be widely shared and Korean herbal medicinal preparations be further developed.

• 한국방사선학회논문지
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• 제7권6호
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• pp.397-402
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• 2013

우리나라 약사법과 외국의 방사성의약품 제조관리기준 가이드라인을 참고하여 방사성의약품 제조관리기준 제정 시 고려해야할 사항들에 대해 의견을 제시하였다. 의약품은 안전성, 유효성과 더불어 제품의 균일성이 검증되어야 한다. 따라서 방사성의약품의 특성을 충분히 고려한 합리적인 제조관리기준을 제정하면 방사성의약품 관리의 효율성을 증대시키고 국민건강 증진에 기여할 수 있을 것으로 기대된다.

• 의료법학
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• 제24권2호
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• pp.119-145
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• 2023

약사법은 의약품 조제의 경우 복약지도를 의무사항으로 규정하고 있음에도 불구하고, 실제로 이루어지고 있는 복약지도의 내용을 보면 복용량과 시간만을 알려주는 것에 불과한 경우가 많다. 그런데 비대면진료를 시도하는 현 상황에 비추어 볼 때, 복약지도 미비를 원인으로 하여 약화사고가 발생하기 쉽다는 우려가 상당하다. 또한, 고령화 사회가 진전됨에 따라 의약품에 대한 설명의 필요성이 증가하고 있다. 관련하여, 약사의 복약지도의무 위반으로 인하여 적절한 복용이 이루어지지 않아 환자에게 손해가 발생한 경우, 환자측은 알권리 및 자기결정권, 신체적 인격법익과 재산적 법익의 침해를 이유로 손해배상을 청구할 수 있다. 그런데 의약품 조제의 경우와 같이 의약품 사고가 약사의 복약지도의무와 의사의 설명의무가 경합하여 발생한 경우 약사와 의사의 공동불법행위가 성립할 것임에도, 의사의 설명의무 위반으로 인하여 약사의 복약지도의무 위반이 다투어지지 않는 경우가 있다. 현행 약사법은 복약지도의 내용에 일반의약품 선택을 위한 정보 제공 역시 복약지도 의무의 범주에 포함시키고 있는바, 복약지도의무의 중요성을 재고하기 위하여 의약품정보 제공행위와 복약지도의무를 별개의 개념으로 나누어 규정할 필요가 있다. 또한 복약지도가 의약품의 부작용이나 병용의약품과의 상호작용 등에 이르기까지 자세한 내용으로 이루어질 수 있도록 관련 규정을 환자 중심으로 개정할 필요가 있다.

• 한국의사학회지
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• 제28권1호
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• pp.81-92
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• 2015

Objectives : The purpose of this study is to analyze and identify the problems of current laws and regulations regarding preparation and processing of herbal medicines at hospitals of Korean Medicine. Possible solutions are proposed in the end Methods : Based on the status of hospitals of Korean Medicine and characteristics of Korean Medicine and Korean Medicine industry, I analyze the laws and regulations in regards to preparation and processing of herbal medicines and propose possible solutions. Results : Regulations for the agents, places, and cautions in respect of preparation and processing of herbal medicines are inadequate. Meanwhile, the definition of drug preparation in the Pharmaceutical Affairs Act does not apply to processing and preparation of herbal Medicines at hospitals of Korean Medicine, since herbal medicines accompanies chemical and physical change. Discussions & Conclusions : New regulations for on-site preparation at hospitals of Korean Medicine are necessary. Also, the definition for herbal medicines preparation, which states possible chemical and physical changes of herbal medicines, should be specified in Pharmaceutical Affairs Act.

• 대한한의학회지
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• 제36권1호
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• pp.61-74
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• 2015

Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of 'Crude drugs' does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term 'Crude drug preparations', and we should use term 'Herbal medicinal preparations' in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.

• 한국의사학회지
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• 제26권2호
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• pp.9-21
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• 2013

Purpose : The purpose of this study was to analyze the history and characteristics of laws and regulations of the medical and pharmaceutical system in Korea-focusing on the Korean (Oriental) medical and pharmaceutical system-from the modern period to the early days of the Republic. We reviewed how traditional notions and categories of Oriental medicine, which were regarded as experiential and conventional, became part of the current dualistic medical and pharmaceutical system, and examined problems and effects during the course of positioning. Methods : We classified the development of the medical and pharmaceutical laws and regulations chronologically, from the Korean Empire to the beginning of the Republic. The abolishment of the traditional medical system that was based on laws and regulations of the Joseon Dynasty, the implementation of dualistic medical system in the Korean Empire, the attempt to demolish Korean (Oriental) medicine under the Japanese colonial rule, and the process of developing a statute-based continental law system were thoroughly reviewed. Results : Although the dualistic medical system was specified in legislation via the enactment of the National Medical Services Law in 1951, we found that it was actually enacted in 1963, when the laws and systems regarding the educational institution of Korean (Oriental) medicine were stably established. Moreover, the dualistic pharmaceutical system was specified in legislation through the partial amendment of the Pharmaceutical Affairs Act in 1994, but we concluded that the actual enactment was rather in 2000, when the first Korean (Oriental) pharmacist was produced. Discussions and conclusions : An effort to establish a dualistic medical system of Korean (Oriental) medicine and Western medicine during the Korean Empire bore fruit a few decades later, after the Republic of Korea was founded. It means the basis for the legal system finally took shape in spite of the numerous attempts during the Japanese colonial era and the beginning of the Republic to abolish Korean (Oriental) medical and pharmaceutical system.